A pre-visit questionnaire and guided conversation to improve survivorship care in oncology outpatient visits
FRAME (Focused Recognition, Assessment and Management of Late Effects): A Single-Center Implementation Study Using RE-AIM to Guide Evaluation in the Department of Oncology, Vejle Hospital
NA · Vejle Hospital · NCT07281820
This project tests whether a short pre-visit questionnaire plus a guided conversation and tailored follow-up can help cancer survivors and their clinicians manage late effects during routine oncology outpatient visits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Vejle Hospital (other) |
| Locations | 1 site (Vejle, Region Syddanmark) |
| Trial ID | NCT07281820 on ClinicalTrials.gov |
What this trial studies
FRAME embeds a patient-reported questionnaire (FRAME-PRO) into routine oncology outpatient visits so patients and informal caregivers can reflect on late effects before the appointment. Clinicians use the FRAME-PRO responses during the visit to prioritize concerns, triage severity, and co-create a documented management plan with stepped referrals across primary care, hospital supportive services, and specialized late-effects clinics. Implementation strategies draw on ERIC methods (education, audit and feedback, reminders, local champions, technical assistance) and the project measures implementation with the RE-AIM framework supplemented by Proctor implementation outcomes. Data come from the Mit Sygehus app, departmental registries, bespoke questionnaires, fidelity checklists, and qualitative interviews, with quantitative summaries and content analysis of qualitative data.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors attending outpatient oncology visits at Vejle Hospital who can complete the pre-visit FRAME-PRO questionnaire and participate in a guided discussion with their clinician.
Not a fit: Patients who do not receive care at Vejle Hospital, cannot use the electronic app, or require acute inpatient care are unlikely to benefit from this outpatient implementation.
Why it matters
Potential benefit: If successful, FRAME could make survivorship visits more focused on what matters to patients, increase appropriate referrals, and improve coordination of late-effects care.
How similar studies have performed: PRO-based care models in oncology have improved symptom recognition and service use in prior studies, but applying them specifically to survivorship care and cross-sector management in routine outpatient clinics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period. Exclusion Criteria: \- None. Participants for interviews: * A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch * written and verbally informed consent.
Where this trial is running
Vejle, Region Syddanmark
- Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark — Vejle, Region Syddanmark, Denmark (RECRUITING)
Study contacts
- Study coordinator: Johanne D Lyhne, PhD
- Email: JOHANNE.DAM.LYHNE@RSYD.DK
- Phone: 004522910740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Late Effects, Patient-reported outcomes, Survivorship, Oncology, Implementation science, RE-AIM, Proctor Outcomes